MAUDE Adverse Event Report: ARTHREX, INC. TIGERTAPE; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	TIGERTAPE
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Excessive Tear Production (2235)
Date of Event	09/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined.The device was not returned for evaluation as it remained in the patient and therefore the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.A possible cause of this type of event may be a reaction of the patient to the material(s) implanted or used during the implant procedure.Product directions for use warns of effects like foreign body and allergic-like reactions as well as infections both deep and superficial to the implant materials.Patient sensitivity to materials must be considered prior to implantation.
Event or Problem Description
It was reported by the patient that she had shoulder surgery on (b)(6) 2018 to repair a rotator cuff tear and some other shoulder issues.During the surgery patient had a lateral swivelock anchor implanted.The patient has had ongoing hives all over her body which began almost the following day after surgery.Patient has known allergies to many foods, animals, etc.But has never had this issue prior to the surgery.Patient is going to obtain the actual arthrex product number and will provide.Additional information obtained 12/18/18: patient has provided the part/lot number of the implant she received: ar-2324bcc, lot 10222118, swivelock anchor.Also used during the surgery was ar-7237-7t, lot 10180403, tiger tape.The material composition of the devices has been provided to the patient.

• Brand Name: TIGERTAPE
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8209131
• Report Number: 1220246-2019-00825
• Device Sequence Number: 13867123
• Product Code: GAT
• UDI-Device Identifier: 00888867041776
• UDI-Public: 00888867041776
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K122374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: TIGERTAPE
• Device Catalogue Number: AR-7237-7T
• Device Lot Number: 10180403
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2018
• Initial Report FDA Received Date: 01/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other